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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Folders And Injectors, Intraocular Lens (Iol)
510(k) Number K112977
Device Name MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
Applicant
Alcon Research, Ltd.
6201 S. Fwy.
Fort Worth,  TX  76134
Applicant Contact Catherine Goble
Correspondent
Alcon Research, Ltd.
6201 S. Fwy.
Fort Worth,  TX  76134
Correspondent Contact Catherine Goble
Regulation Number886.4300
Classification Product Code
MSS  
Date Received10/06/2011
Decision Date 03/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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